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430307008

Refrigerated Storage

CimziaUCB Pharma

UCB Pharma
Cimzia
200mg solution for injection in pre-filled syringe/pre-filled pen

In the event of an inadvertent temperature excursion the following data may be used:
The pre-filled pens/pre-filled syringes may be stored at room temperature (up to 25°C) for a single period of up to a maximum of 10 days with protection from light.

If the product has been left outside of the fridge and if the next scheduled dose is within 10 days after the start of the storage above 8°C, the product should be left outside of the fridge (at a temperature of up to 25°C) and injected according to the dosing schedule. If the next scheduled dose is more than 10 days after the start of the storage above 8°C, the pack may be returned to the fridge. Once the product has been returned to the fridge it cannot be subjected to further temperature excursions.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

No if exposed to conditions described above
Yes if exposed to conditions described above

Do not freeze. Certolizumab pegol should be injected at room temperature. It will take approximately 30-45 minutes to warm to room temperature once certolizumab pegol has been removed from the refrigerator

9 November 2020
London MI service

Lactation Safety Information

For rheumatoid arthritis

For rheumatoid arthritis
Yes
See summary
Moderate amount of published evidence of safety indicates negligible amounts in breast milk which are likely to be degraded in the infant’s GI tract
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
15 September 2019

For psoriasis

For psoriasis
Yes
Topical psoriasis preparation / corticosteroid if appropriate
Moderate amount of published evidence of safety indicates negligible amounts in breast milk which are likely to be degraded in the infant’s GI tract
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
16 September 2019

New Medicines

CimziaModerate-to severe chronic plaque psoriasis in adults

Information

Cimzia
Licence extension / variation
UCB Pharma
Dermira

Development and Regulatory status

Launched
Launched
Launched
July 2018
Jan 20The new dose dispenser cartridge is licensed for treating adults with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and plaque psoriasis [11].
Jan 20SPC for new dose dispenser cartridge published on eMC. Contact UCB for UK availability information [11].
Mar 19New administration device approved in EU using a 200mg dose-dispenser cartridge [10].
Jul 18Approved in EU [9].
May 18Approved in US [8].
Apr 18Recommended for approval by CHMP: the additional indication is "for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy" [7].
Jul 17Filed in US & EU for treatment of adult patients with moderate-to-severe chronic plaque psoriasis [6].
Jan 17UCB intends to submit marketing applications to regulatory authorities in Q3 2017 [4]
Oct 16Dermira have marketing rights in US and Canada [2].

Category

Anti-cytokine antibody fragment that binds to tumour necrosis factor (TNF)-α.
Prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK, with the highest prevalence being in white people. Men and women are equally affected. Plaque psoriasis accounts for 90% of all people with psoriasis [1].
Moderate-to severe chronic plaque psoriasis in adults
Subcutaneous

Further information

Yes
April 2019

Trial or other data

Mar 17PIII RCT, CIMPASI-2 (NCT02326272, n= 227) meets co-primary endpoints. At week 16, 82.6% of patients given 400mg certolizumab achieved PASI 75 vs. 81.4% on 200mg and 11.6% on placebo. Two-point improvement to final score of clear/almost clear on PGA scale achieved in 71.6%, 66.8% and 2.0%, respectively [5].
Dec 16PIII RCT, CIMPASI-1 (NCT02326298, n=234) meets co-primary efficacy endpoints. At week 16, 75.8% of patients given 400mg certolizumab achieved PASI 75 vs. 66.5% on 200mg and 6.5% on placebo. Two-point improvement to final score of clear/almost clear on Physician’s Global Assessment scale achieved in 57.9%, 47.0% and 4.2%, respectively [3].
Oct 16CAMPASI-2, is a PIII 16-week RCT (n=227) evaluating two separate dosing regimens of certolizumab (400 mg every two weeks n=87) or 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks) vs placebo. Co-primary endpoints are proportion of patients with a Psoriasis Activity and Severity Index (PASI75) response and proportion of patients with a Physician´s Global Assessment Clear or Almost Clear response at Week 16 [2].
Oct 16UCB and Demira announces NCT02326272 (CIMPASI-2) met its primary efficacy endpoints at both treatment doses [2].

Evidence based evaluations

CimziaJuvenile idiopathic arthritis in adolescents and children

Information

Cimzia
Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Anti-cytokine antibody fragment that binds to tumour necrosis factor (TNF)-α.
Prevalence of SJIA is estimated to be 1-2 per 1,000 children [2].
Juvenile idiopathic arthritis in adolescents and children
Subcutaneous